Regulatory Program Manager - Health
Apple
Regulatory Program Manager - Health
Job Description
Our ever-evolving suite of health and wellness products are helping our users live more active, healthier lives. Be ready to make something great when you come here. Dynamic, inspiring people and innovative, industry-defining technologies are the norm at Apple. The people who work here have reinvented and defined entire industries with our products and services. The same dedication to innovation also applies to our approach to health - strengthening our commitment to leave the world better than we found it. The Regulatory Program Manager supports the launch of regulated health features, directly contributing to our users' healthier lives worldwide. You will build relationships across Apple's diverse teams to support regulatory efforts and enable global feature availability. The Program Manager will provide comprehensive support for all global submissions, product launches, design changes, and policy interactions. Responsibilities include: • Oversee regulatory submissions, launch readiness, design changes, and medical device policy activities for the medical device portfolio • Establish a robust understanding of the overall critical path to coordinate activities and resolve problems alongside multi-functional partners • Communicate program status and escalate risks to a variety of partners • Establish and lead Design History File documentation timelines and successful execution across multiple stakeholders This is a site-based role and may require occasional travel.
Locations
- San Francisco Bay Area, California, United States
Salary
Estimated Salary Rangemedium confidence
25,000,000 - 50,000,000 INR / yearly
Source: ai estimated
* This is an estimated range based on market data and may vary based on experience and qualifications.
Skills Required
- building relationshipsintermediate
- regulatory submissions oversightintermediate
- launch readiness managementintermediate
- design changes managementintermediate
- medical device policy activitiesintermediate
- critical path understandingintermediate
- activity coordinationintermediate
- problem resolutionintermediate
- multi-functional partner collaborationintermediate
- program status communicationintermediate
- risk escalationintermediate
- Design History File documentationintermediate
- stakeholder managementintermediate
- timeline establishment and executionintermediate
Required Qualifications
- Bachelor’s degree, preferably in engineering, science, business or equivalent field (degree in engineering)
- 8+ years of program/project management experience in a regulated industry, preferably in medical products and/or digital health (experience, 8 years)
- Proven understanding of regulatory process for different classes of medical devices in both the US and internationally (experience)
- Consistent track record of driving regulatory submissions and launches with multi-disciplinary teams (experience)
- Outstanding communication and organizational skills. Ability to efficiently handle multiple projects simultaneously (experience)
Preferred Qualifications
- Master’s degree, preferably in engineering, science, business or equivalent field (degree in engineering)
- 10+ years of program/project management experience in a regulated industry, preferably in medical products and/or digital health (experience, 10 years)
- Consistent track record of driving quality system updates and regulator engagements (experience)
- Experience with implementation of tools and systems for process management (experience)
- Excellent analytical and problem-solving capabilities, with a keen eye to detect and mitigate risks (experience)
- Independent self-starter who thrives in ambiguous environments (experience)
- Hands-on experience in the use of project management and reporting software (experience)
Responsibilities
- The Program Manager will provide comprehensive support for all global submissions, product launches, design changes, and policy interactions. Responsibilities include:
- • Oversee regulatory submissions, launch readiness, design changes, and medical device policy activities for the medical device portfolio
- • Establish a robust understanding of the overall critical path to coordinate activities and resolve problems alongside multi-functional partners
- • Communicate program status and escalate risks to a variety of partners
- • Establish and lead Design History File documentation timelines and successful execution across multiple stakeholders
- This is a site-based role and may require occasional travel.
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Regulatory Program Manager - Health
Apple
Regulatory Program Manager - Health
Job Description
Our ever-evolving suite of health and wellness products are helping our users live more active, healthier lives. Be ready to make something great when you come here. Dynamic, inspiring people and innovative, industry-defining technologies are the norm at Apple. The people who work here have reinvented and defined entire industries with our products and services. The same dedication to innovation also applies to our approach to health - strengthening our commitment to leave the world better than we found it. The Regulatory Program Manager supports the launch of regulated health features, directly contributing to our users' healthier lives worldwide. You will build relationships across Apple's diverse teams to support regulatory efforts and enable global feature availability. The Program Manager will provide comprehensive support for all global submissions, product launches, design changes, and policy interactions. Responsibilities include: • Oversee regulatory submissions, launch readiness, design changes, and medical device policy activities for the medical device portfolio • Establish a robust understanding of the overall critical path to coordinate activities and resolve problems alongside multi-functional partners • Communicate program status and escalate risks to a variety of partners • Establish and lead Design History File documentation timelines and successful execution across multiple stakeholders This is a site-based role and may require occasional travel.
Locations
- San Francisco Bay Area, California, United States
Salary
Estimated Salary Rangemedium confidence
25,000,000 - 50,000,000 INR / yearly
Source: ai estimated
* This is an estimated range based on market data and may vary based on experience and qualifications.
Skills Required
- building relationshipsintermediate
- regulatory submissions oversightintermediate
- launch readiness managementintermediate
- design changes managementintermediate
- medical device policy activitiesintermediate
- critical path understandingintermediate
- activity coordinationintermediate
- problem resolutionintermediate
- multi-functional partner collaborationintermediate
- program status communicationintermediate
- risk escalationintermediate
- Design History File documentationintermediate
- stakeholder managementintermediate
- timeline establishment and executionintermediate
Required Qualifications
- Bachelor’s degree, preferably in engineering, science, business or equivalent field (degree in engineering)
- 8+ years of program/project management experience in a regulated industry, preferably in medical products and/or digital health (experience, 8 years)
- Proven understanding of regulatory process for different classes of medical devices in both the US and internationally (experience)
- Consistent track record of driving regulatory submissions and launches with multi-disciplinary teams (experience)
- Outstanding communication and organizational skills. Ability to efficiently handle multiple projects simultaneously (experience)
Preferred Qualifications
- Master’s degree, preferably in engineering, science, business or equivalent field (degree in engineering)
- 10+ years of program/project management experience in a regulated industry, preferably in medical products and/or digital health (experience, 10 years)
- Consistent track record of driving quality system updates and regulator engagements (experience)
- Experience with implementation of tools and systems for process management (experience)
- Excellent analytical and problem-solving capabilities, with a keen eye to detect and mitigate risks (experience)
- Independent self-starter who thrives in ambiguous environments (experience)
- Hands-on experience in the use of project management and reporting software (experience)
Responsibilities
- The Program Manager will provide comprehensive support for all global submissions, product launches, design changes, and policy interactions. Responsibilities include:
- • Oversee regulatory submissions, launch readiness, design changes, and medical device policy activities for the medical device portfolio
- • Establish a robust understanding of the overall critical path to coordinate activities and resolve problems alongside multi-functional partners
- • Communicate program status and escalate risks to a variety of partners
- • Establish and lead Design History File documentation timelines and successful execution across multiple stakeholders
- This is a site-based role and may require occasional travel.
Tags & Categories
Answer 10 quick questions to check your fit for Regulatory Program Manager - Health @ Apple.
10 Questions
~2 Minutes
Instant Score
Related Books and Jobs